Questions and Answers 2PAM AI (Parts 1-4).pdf

Questions and Answers (Part 1) 2-PAM Autoinjectors

Government responses are in red.

• Evaluation Criterion 1: Technical Manufacturing Capabilities - Safety considerations (e.g., unintended injection prevention features and needle shield, when applicable). Can BARDA provide clarification on "when applicable?" Are autoinjectors with exposed needles post-dose excluded from this Notice?

“When applicable” refers specifically to the needle shield. No autoinjector design is specifically required or excluded; however offerors should bear in mind that this product is being developed for civilian (general public) use. Proposals that take safety considerations into account will rate higher.

• Section 2. - This RFP only covers late-stage clinical development and regulatory, no late-stage

R&D (example, design verification or human factors validation), is this correct?

Human factors studies are considered clinical development.

• M3 Mandatory Qualification Criteria - for point one (1) on facilities, infrastructure and equipment to manufacture, does this mean full commercial scale equipment needs to be in place by August 15th? Or is it sufficient for equipment to be at FAT and in place/qualified by award?

For Mandatory Qualification Criteria on manufacturing capacity, the offeror doesn’t have to have the commercial scale equipment in place by August 15th. However, the offeror must provide information that supports their ability to be able to meet procurement numbers and timeline as stated in the RFP.

• M3 Mandatory Qualification Criteria - for point two (2) on the reliability requirement, does the FDA feedback need to be specific to the proposed autoinjector for 2-PAM or can it be non-product specific feedback on reliability methodology being used for other products within the same product line/portfolio?

FDA feedback on an offeror’s autoinjector platform is acceptable, as long as it is the same autoinjector platform that is being proposed for the 2-PAM AI RFP.

• General - This is a substantial RFP for such a short turnaround. Would BARDA consider an extension on the proposal submission date of August 15?

BARDA cannot consider an extension of the proposal submission date.

Questions and Answers (Part 2)

• The RFP mentions a dose of 600mg on one side and a target population of adults and children above 2 years of age on the other side. According to available data, a 600mg dose of 2-PAM can be used for children and adults above 40kg. Can BARDA comment on this?

The FDA approved dose and indication for pediatrics for the approved 2PAM DuoDote is what BARDA is referring to for pediatric use.

• Can the pediatric population be narrowed down to the population above 40kg, or does a different dosage need to be developed, and new CLINs specified by BARDA for this particular dosage reference procurement?

Yes, pediatric population of >40kg is acceptable. The government is not interested in developing new doses or pediatric specific autoinjectors as part of this procurement.

• Would the government accept a proposal from a Canadian company?

Yes

• Can the device route of administration be Subcutaneous (SQ) rather than intramuscular

(IM)?

The approved 2PAM in the MARK 1 kits and DuoDote are approved for IM; however, all devices and routes will be considered if the proposed device has regulatory feedback from the FDA for their device and 2PAM and can meet the required criteria as described in the RFP.

• Would the government consider a non-disposable device?

No

• Would the government accept a multi-use device?

No.

• Is it a requirement that the autoinjector be pre-filled?

Yes

• Would the government accept a filled separate cartridge that is stored separately; then inserted into the stand-alone device prior to administration?

• Would it be acceptable to obtain regulatory approval for the pediatric autoinjector(s) in the option period?

The Government is not interested in developing new doses or pediatric specific autoinjectors as part of this procurement.

• If the initially FDA-approved product has a 1-year shelf-life, is it appropriate to propose

VMI storage by the contractor until the final 3-year shelf life is achieved and the product is relabeled? This approach would avoid having to ship the product back from the SNS for relabeling.

• Can BARDA provide guidance on the number of SNS locations and the shipping distances to SNS locations? Will the shipping quantities be evenly distributed between the SNS locations?

The delivery of the devices is directly to the SNS, at a location or locations of their choosing.

• Can BARDA provide guidance on developing cost proposals for post-marketing commitments/requirements in the absence of guidance from the FDA?

While the government realizes that post marketing commitments cannot be perfectly predicted, offerors should base their proposals on best estimates and prior experience.

• Can BARDA confirm that a trainer device will not be required?

Trainers are likely to be required and will be a subject for negotiation.

Questions and Answers (Part 3)

• Is the project looking to recreate the existing 2PAM or does this RFP require a newly designed autoinjector?

The RFP is agnostic on this point. However, 2-PAM autoinjectors must demonstrate compliance with FDA reliability standards outlined in the Draft Guidance for Technical Considerations for Demonstrating Reliability of Emergency-Use Injectors Submitted under a BLA, NDA or ANDA.

The 2-PAM autoinjector must achieve FDA approval as a drug/device combination product, for the treatment of OP poisoning, including nerve agents, in (civilian) adult and pediatric populations.

• Could you please provide details regarding primary container – dims, volume, components, container type, etc.

These parameters are not specified.

• Fill volume / concentration details

The autoinjectors must be suitable for IM administration of a 600 mg dose of 2-PAM

• Are both auto-injectors in scope? It appears only Pralidoxime autoinjector is required.

This acquisition will allow BARDA to invest Project Bioshield funds for late-stage clinical development, regulatory approval for 2-PAM autoinjectors (as a drug/device combination product).

Questions and Answers (Part 4)

• The link in Attachment 7 (HHS 508 Product Assessment Template) is broken. Please provide a working link to the form intended for Offerors to evaluate and complete.

This is no longer required, please ignore

• Section C.1.3 states Offeror shall submit a copy of their security plan and that of all subcontractor security plans with submission. Given the date for proposal for proposal submission this may be difficult, and suppliers may be reluctant to provide these sensitive documents on a tenuous basis (meaning no subcontract unless Offeror being selected for the 2- PAM contract). Can these be submitted after award?

• Section H.1.1 states proposal; does not involve use of animals. In some instances the regulatory status of an autoinjector may enable Offeror to petition FDA for a clinical trial exemption based on animal studies of the 2-PAM combination device with previous combination devices delivering other similar drugs. Offeror can save the government significant time and cost by first obtaining FDA agreement to accept animal studies as a surrogate for human studies and leading to EUA/NDA submission.

Yes, if animal studies are needed

• Section H.27. refers to data sharing. Is this considered accomplished by submission of data and reports to BARDA, or is there a separate BARDA data repository intended for delivery of shared data?

Yes. BARDA will have the rights to share the data submitted as deemed necessary as described in Section H.27.

• Section L.2.1 states there are 3 sections to a submission L.2.4.B ) Mandatory Qualification

Criteria; L.2.4.C) Technical Proposal and L.2.4.D) Business Proposal. As described, these are three separate parts to the whole proposal. Will reviewers of the Technical Proposal have access to content from the Mandatory Qualification Criteria (MQC) part such that the Offeror can make a reference in the Technical Proposal to attachment contents in the MQC and not have to duplicate this content again in attachments to the Technical Proposal?

No. Treat each proposal as separate stand-alone documents.